510(k) Report

FDA product code · Ear, nose and throat

Oral Irrigation Kit

OGTClass I21 CFR 872.65100 decisions0 recalls

0 FDA decisions. No recall names this code.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ear, nose and throat panel

Twenty years of OGT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OGT

FDA has decided no OGT device since 2007.

Median 510(k) review, days · OGT

Too few OGT 510(k)s in any year since 2007 to give a median.

Recalls per year · OGT

No recall names OGT since 2007.

Adverse event reports per year · OGT

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code OGT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — OGT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OGT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 872.6510.

EFS Unit, Oral Irrigation